Expert Opinion on Management of Intraocular Inflammation, Retinal Vasculitis, and Vascular Occlusion after Brolucizumab Treatment

Baumal, Caroline R.; Bodaghi, Bahram; Singer, Michael; Tanzer, David J.; Seres, András; Joshi, Mayur R.; Feltgen, Nicolas; Gale, Richard

doi:10.1016/j.oret.2020.09.020

Cited by 120 publications

(171 citation statements)

References 27 publications

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“…At 3.3% and 2.1%, respectively, the rates of brolucizumab-associated retinal vasculitis and vascular occlusion were significantly higher than those reported in the original HARRIER and HAWK studies. However, despite the potential for vision loss from these events, the overall rate of moderate-to-severe vision loss (≥15 ETDRS letters) in the HARRIER and HAWK trials was similar between brolucizumab (7.4%) and aflibercept (7.7%) [ 62 ].…”

Section: Brolucizumab-associated Retinal Vasculitismentioning

confidence: 99%

“…The diagnosis can be established in patients who have received intravitreal brolucizumab within the past 8 weeks, where clinical evidence of vasculitis is present, and if infectious endophthalmitis is unlikely. In cases where only signs of SII are present, close follow-up is recommended, and serial fluorescein angiography (FA) with peripheral sweeps should be considered to assess for evidence of subtle vasculitis or retinal occlusive events [ 62 ]. However, the therapeutic effect of brolucizumab may diminish some vasculitis-associated FA findings, such as hyperfluorescence and staining of the vessel wall or fluorescein leakage.…”

Section: Brolucizumab-associated Retinal Vasculitismentioning

confidence: 99%

“…This difference may be due to arterial occlusion, the anti-VEGF effect of brolucizumab, or that the two conditions are simply unrelated. Additional factors, such as HLA subtype, immune status, causative comorbidities, or prior exposure to compounds structurally similar to brolucizumab, may also factor into BARV pathogenesis [ 62 ].…”

Section: Brolucizumab-associated Retinal Vasculitismentioning

confidence: 99%

“…As results of this trial become available, they may better elucidate the factors that predispose patients to developing BARV. Until such evidence is forthcoming, expert opinion has offered guidelines on managing these patients, including educating brolucizumab patients on urgent follow-up for relevant symptoms, evaluation for vasculitis or vascular occlusion in patients with post-injection intraocular inflammation, consideration of imaging modalities to aid in diagnosis, and aggressively treating affected patients with corticosteroids, and suspension of brolucizumab therapy while BARV is active [ 62 ].…”

Section: Brolucizumab-associated Retinal Vasculitismentioning

confidence: 99%

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Inflammatory Complications of Intravitreal Anti-VEGF Injections

Cox

Eliott

Sobrin

2021

JCM

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Intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents is a commonly used therapy for numerous retinal diseases. The most commonly used of these medications are bevacizumab, ranibizumab, aflibercept, and brolucizumab. However, intravitreal administration of these agents is also associated with several inflammatory and non-inflammatory adverse events. The three inflammatory adverse events are sterile intraocular inflammation, brolucizumab-associated retinal vasculitis, and post-injection endophthalmitis. This narrative review summarizes the current literature regarding these conditions, including their epidemiology, presentation, management, outcomes, and pathogenesis. The inflammatory adverse events also share a number of overlapping features, which can make them difficult to discern from one another in a clinical context. This review discusses certain distinguishing features of these conditions that may aid providers in discerning between them and establishing the correct diagnosis.

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Section: Brolucizumab-associated Retinal Vasculitismentioning

confidence: 99%

Section: Brolucizumab-associated Retinal Vasculitismentioning

confidence: 99%

Section: Brolucizumab-associated Retinal Vasculitismentioning

confidence: 99%

Section: Brolucizumab-associated Retinal Vasculitismentioning

confidence: 99%

See 2 more Smart Citations

Inflammatory Complications of Intravitreal Anti-VEGF Injections

Cox

Eliott

Sobrin

2021

JCM

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“…4 Die Aufklärung sollte neben den bisherigen Risiken und Symptomen der infektiösen Endophthalmitis auch explizit Beschwerden wie Rötung, Glaskörpertrübung und Visusminderung auch im späteren Verlauf einschließen in Differenzierung zur bekannten typischen zeitlichen Manifestierung einer Post-IVOM-Endophthalmitis, die zumeist in den ersten 3 Tagen symptomatisch wird. Bisherigen Beobachtungen zufolge traten unerwartete Ereignisse im Spätverlauf (Durchschnitt 25 Tage [3 bis 63 Tage] post injectionem) auf [26]; 48 % der intraokularen Entzündungen ereigneten sich während der ersten 3…”

Section: Intraokulare Entzündungen Bei Brolucizumab-anwendung Patientenmanagement -Diagnose -Therapieunclassified

Intraocular inflammation with brolucizumab use

et al. 2021

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ZusammenfassungDer VEGF(„vascular endothelial growth factor“)-Inhibitor Brolucizumab ist seit Oktober 2019 in den USA und seit Februar 2020 in Europa zur Behandlung der neovaskulären altersabhängigen Makuladegeneration (nAMD) zugelassen. Grundlage der Zulassung bildeten die randomisierten, doppel-blinden Phase-III-Studien HAWK und HARRIER mit insgesamt 1817 Patienten. Hierbei zeigte Brolucizumab 6 mg (je nach Krankheitsaktivität alle 12 oder alle 8 Wochen verabreicht) eine nichtunterlegene Wirksamkeit in Bezug auf den bestkorrigierten Visus gegenüber Aflibercept 2 mg (alle 8 Wochen verabreicht). Erste Rückmeldungen zum Einsatz von Brolucizumab nach der Marktzulassung in den USA haben einzelne, z. T. schwerwiegende Fälle behandlungsassoziierter intraokularer Entzündungen mit retinaler Vaskulitis und/oder retinaler, vaskulärer Okklusion beschrieben, die teilweise zu einem schweren Visusverlust führten. Die Daten der Zulassungsstudien wurden daraufhin durch ein Safety Review Committee (SRC) unabhängig retrospektiv analysiert. Ziel der vorliegenden Publikation ist es, Anwendern eine Orientierungshilfe aus Autorensicht bei der Therapie einer Brolucizumab-assoziierten intraokularen Entzündung zu bieten. Von zentraler Bedeutung ist hierbei auch eine erweiterte Aufklärung der Patienten über Symptome einer intraokularen Entzündung. Obwohl die Fallserien und die HAWK/HARRIER-Daten es nicht abschließend beantworten, bleiben eine zu späte Detektion, eine unterdosierte antientzündliche Therapie oder eine unbedachte Wiederbehandlung mit Brolucizumab dem Verdacht ausgesetzt, Komplikationen zu verstärken. Ein Stopp der Brolucizumab-Therapie sollte grundsätzlich erfolgen, sobald es nach Gabe des Medikaments zu intraokularen Entzündungen mit oder ohne retinalen Vaskulitiden und oder Gefäßverschluss kam. Abhängig vom Schwerpunkt der Entzündung werden dem Behandler an die Leitlinien und Stellungnahmen angelehnte Empfehlungen für Diagnostik und Therapie dargestellt. Diese Übersichtsarbeit ersetzt nicht die fachgesellschaftlichen Stellungnahmen.

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Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration

et al. 2022

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Key Points Question What are the incidence rates and risk factors for intraocular inflammation (IOI) and/or retinal vascular occlusion (RO) after brolucizumab treatment for neovascular age-related macular degeneration (AMD) in clinical practice? Findings In this cohort study of patient eyes with neovascular AMD treated with brolucizumab, the incidence rate for any form of IOI and/or RO was approximately 2.4%. A history of IOI and/or RO was a key risk factor for IOI and/or RO after brolucizumab treatment initiation. Meaning These early findings explore potential risk factors for inflammation-associated adverse events that may occur following real-world treatment with brolucizumab.

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Expert Opinion on Management of Intraocular Inflammation, Retinal Vasculitis, and Vascular Occlusion after Brolucizumab Treatment

Cited by 120 publications

References 27 publications

Inflammatory Complications of Intravitreal Anti-VEGF Injections

Inflammatory Complications of Intravitreal Anti-VEGF Injections

Intraocular inflammation with brolucizumab use

Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration

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